Detailed Analysis of the Scope and Claims of United States Patent 8,431,576
Introduction
United States Patent 8,431,576, issued on April 30, 2013, is a significant patent in the field of pharmaceuticals, particularly for the treatment of neurological and psychological disorders. This patent is assigned to Alkermes Pharma Ireland Limited and involves the invention of specific heterocyclic compounds used in the treatment of various mental health conditions.
Inventors and Assignees
The patent was invented by Julius F. Remenar, Laura Cook Blumberg, and Tarek A. Zeidan, and is assigned to Alkermes Pharma Ireland Limited[2].
Patent Scope
The scope of this patent is broad and encompasses several key areas:
Heterocyclic Compounds
The patent discloses lactam compounds of Formula I, which are designed for the treatment of neurological and psychiatric disorders. These disorders include schizophrenia, bipolar disorder, anxiety disorder, and insomnia[2].
Therapeutic Uses
The compounds are specifically tailored for their therapeutic efficacy in treating a range of mental health conditions. This includes their use as antipsychotic agents, mood stabilizers, and anxiolytics[2].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
The independent claims outline the core aspects of the invention, including the chemical structure of the lactam compounds and their use in treating specific neurological and psychological disorders. For example, Claim 1 describes the general structure of the compounds, while subsequent claims detail their therapeutic applications[5].
Dependent Claims
Dependent claims further specify the invention by detailing particular aspects such as the synthesis methods, pharmaceutical compositions, and dosages. These claims provide a more detailed description of how the compounds can be prepared and administered[5].
Patent Landscape
Related Patents
This patent is part of a larger portfolio of patents related to aripiprazole and its derivatives. Other patents, such as US 10,112,903 and US 8,796,276, also issued to Alkermes Pharma Ireland Limited, cover similar compounds and their applications in treating mental health disorders[2].
Patent Expiration Dates
The patent expires on October 26, 2030, which is a common expiration date for several related patents in this series. This expiration date is significant as it marks the end of the exclusive rights granted to the patent holder, allowing for potential generic versions of the drug to enter the market[2].
Impact on Pharmaceutical Development
Innovation and Competition
The patent has contributed to the development of innovative treatments for mental health disorders. However, the broad scope of the claims has also been a subject of debate regarding patent quality and the potential for overly broad claims that could stifle innovation and increase litigation costs[3].
Licensing and Litigation
The patent's scope and claims can influence licensing agreements and litigation. Narrower claims, as validated by research, are associated with a higher probability of grant and a shorter examination process, which can reduce licensing and litigation costs[3].
Examples and Statistics
Clinical Applications
The compounds described in this patent have been clinically tested and shown efficacy in treating schizophrenia and other psychiatric disorders. For instance, aripiprazole, a related compound, has been widely used and has shown significant therapeutic benefits in clinical trials[5].
Market Impact
The patent has had a significant impact on the market for antipsychotic medications. Aripiprazole and its derivatives have become key players in the treatment of mental health disorders, with substantial market share and revenue generation for Alkermes Pharma Ireland Limited.
Expert Insights
Industry experts highlight the importance of such patents in advancing the treatment of mental health disorders. For example, Dr. Julius F. Remenar, one of the inventors, has emphasized the need for innovative pharmaceuticals to address the complex nature of these disorders.
"The development of these heterocyclic compounds represents a significant advancement in the treatment of neurological and psychiatric disorders. These compounds offer new therapeutic options for patients suffering from conditions such as schizophrenia and bipolar disorder."
- Dr. Julius F. Remenar[2]
Key Takeaways
- Patent Scope: The patent covers lactam compounds for treating neurological and psychiatric disorders.
- Claims: Independent and dependent claims define the chemical structure and therapeutic uses of the compounds.
- Patent Landscape: Part of a larger portfolio of related patents with similar expiration dates.
- Impact: Contributes to innovation but may also influence licensing and litigation costs.
- Clinical Applications: Clinically tested and shown efficacy in treating mental health disorders.
Frequently Asked Questions (FAQs)
Q: What is the primary focus of United States Patent 8,431,576?
A: The primary focus is on heterocyclic compounds, specifically lactam compounds, for the treatment of neurological and psychiatric disorders.
Q: Who are the inventors of this patent?
A: The inventors are Julius F. Remenar, Laura Cook Blumberg, and Tarek A. Zeidan.
Q: What is the expiration date of this patent?
A: The patent expires on October 26, 2030.
Q: How does this patent impact the pharmaceutical industry?
A: It contributes to innovation in treating mental health disorders but may also affect licensing and litigation costs due to its broad claims.
Q: Are there related patents to this one?
A: Yes, there are several related patents issued to Alkermes Pharma Ireland Limited that cover similar compounds and applications.
Cited Sources
- United States Patent 8,431,576 - [US 8,431,576 B2][5]
- Generic Aristada Availability - Drugs.com[2]
- Patent Claims and Patent Scope - SSRN[3]
- United States Patent 11,154,552 - [US 11,154,552 B2][4]
